• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC TM TOTAL ANKLE TALAR COMPONENT KXC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER INC TM TOTAL ANKLE TALAR COMPONENT KXC Back to Search Results
Catalog Number 00830002400
Device Problem Insufficient Information (3190)
Patient Problem Loss of Range of Motion (2032)
Event Type  Injury  
Manufacturer Narrative

Information was received from a foreign consumer who is not required to complete form 3500a. (b)(4). Other device used: catalog #00830004400, tm total ankle tibial base, lot #62615275. Catalog #00830005400, tm total ankle insert component, lot #62861441. This report will be amended when our investigation is complete.

 
Event Description

It is reported that the patient is experiencing dorsiflex. Patient being monitored.

 
Manufacturer Narrative

The trabecular metal total ankle was designed with a minimum of 15 degrees of plantarflexion and 15 degrees of dorsiflexion. However as stated in the instructions for use included with the implant, "total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint. " as described in the article, "postoperative range of motion trends following total ankle arthroplasty" by ajis, henriquez and myerson in the may 2013 issue of the foot and ankle international journal, total ankle replacement does not significantly increase the range of motion of the ankle, but is rather indicative of the preoperative range of motion the patient exhibited prior to the procedure. No devices or photos were returned therefore a determination on the condition of the devices cannot be made. Review of the device history records did not find any deviations or anomalies. The devices were used for treatment. No other complaints of any type have been reported for the provided lots. The reported devices are an approved and compatible combination. With the provided information an exact cause could not be determined.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTM TOTAL ANKLE TALAR COMPONENT
Type of DeviceKXC
Manufacturer (Section D)
ZIMMER INC
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5249816
MDR Text Key32105325
Report Number1822565-2015-02460
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00830002400
Device LOT Number62876087
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/25/2015 Patient Sequence Number: 1
-
-